About the Event

Dr Mary Beth Henderson is the Senior Principal Advisor in Regulatory Affairs and Quality Systems at US based RCRI® (Regulatory & Clinical Research Institute, Inc.).

Dr Henderson will be in Melbourne for the Export Ready for North America Program and will provide an overview of recent FDA updates, shifts, and additions to the medical device regulatory landscape at this BioBriefing.

Areas to be discussed include: when software becomes a medical device, regulatory expectations around digital health devices and cyber security; and the impact of recent guidance in developing regulatory strategies for medical devices.

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